Experience

• 

  Micro labs limited

  Sept 2020 - Mar 2021

  Project intern

  - Assisting in Literature search, review and patent search- Conducting Pre-formulation studies as well as characterization of Innovator Products- Formulation development for Complex Injectables and Protein Peptides Pharmaceutical Products (Depot Microspheres and Protein peptides liquid solutions) for the US regulated Global Market as per the guidance from colleague/superiors- Data compilation regarding product development and all the product development activities as and when required Show less

• 

  Iqvia

  Jan 2022 - now

  Clinical data management

  Data Management Activities• Timely project delivery management, perform Go-live, startup, and database lock activities• Preparation of eCRF, coding guidelines, coding protocol, Data Handling Plan (DHP), Data Review Plan (DRP), Perform User Acceptance Testing (UAT)Clinical Data Coding• Coding using MedDRA and WHO Drug dictionaries• Analyse and interpretate eCRF data (adverse events,medical history, etc.) for data maintenanceenhancementClinical Data Review• Review clinical trial data using Medidata Rave• SAE reconciliation adhering to FDA and ICH guidelinesProject Audits• Quality review and internal QC checks• Generate queries and proposing solutions• Provide data status updates in study team meetingsCross-functional engagement:• Communicate as a clinical Subject Matter Expert (SME) in kick-off meetings• Collaborate with engagement managers, data scientists, and therapeutic experts• Interact with team members, colleagues, and stakeholders for timely project delivery Show less